FDA-Device2017-10-25Class II
Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use
Hologic, Inc
Hazard
An incorrect incubator was installed on one Panther System which potentially led to incorrect Aptima Combo 2(R) assay (AC2) results.
Sold states
Indiana
Affected count
1 unit
Manufactured in
10210 Genetic Center Dr, San Diego, CA, United States
Products
Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0027-2018Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief